Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 1020
Release: 2003-09-05
Genre: Medical
ISBN: 0471459291

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

Safety Evaluation in the Development of Medical Devices and Combination Products

Safety Evaluation in the Development of Medical Devices and Combination Products
Author: Shayne C. Gad
Publisher: CRC Press
Total Pages: 314
Release: 2008-10-20
Genre: Medical
ISBN: 1439809488

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l

Journal

Journal
Author: National Cancer Institute (U.S.)
Publisher:
Total Pages: 834
Release: 1977
Genre: Cancer
ISBN:

Acute Toxicology Testing

Acute Toxicology Testing
Author: Shayne C. Gad
Publisher: Academic Press
Total Pages: 561
Release: 1997-10-27
Genre: Medical
ISBN: 008052592X

Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will interest not only workers in the pharmaceutical industry, but also researchers and students in toxicology and public health.Key Features* Over 100 tables summarizing and interpreting results* Complete coverage of all major test designs and their limitations and advantages* Current status of alternative test designs and models